Regeneron Pharmaceuticals, Inc. v. Merus B.V.
144 F. Supp. 3d 530
S.D.N.Y.2015Background
- Regeneron sued Merus and Ablexis for infringement of U.S. Patent No. 8,502,018 (the '018 Patent); Ablexis settled and Merus counterclaimed for inequitable conduct. The court tried Merus’s inequitable-conduct claim at a bench trial.
- The '018 Patent claims genetically modified mice with human unrearranged immunoglobulin variable region gene segments inserted at an endogenous mouse immunoglobulin locus (uses LTVECs). Regeneron later characterized its commercial embodiment as the "VelocImmune" mouse.
- During prosecution Regeneron emphasized targeted insertion at an endogenous locus (vs. Lonberg random transgenes) and submitted a January 2013 slide presentation asserting VelocImmune embodiments and advantages.
- Merus alleged Regeneron failed to disclose four material prior-art references (Brüggemann, Wood, Taki, Zou) and relevant European opposition briefs to the PTO, and that Regeneron made false/misleading statements to the PTO.
- The court adopted a broadest-reasonable-construction (BRC) of claim 1 (allowing partial human variable segments, insertion without required deletion, "at" means within/into the locus, no requirement of functional linkage or retention of mouse constant region in entirety).
- The court found (1) each withheld reference was but-for material under Therasense given the BRC, (2) Regeneron engaged in affirmative egregious misconduct in prosecution (false/misleading presentation to the PTO), and (3) Regeneron engaged in discovery/trial misconduct (privilege waiver issues, withheld documents), leading to adverse inferences and a finding of inequitable conduct rendering the '018 Patent unenforceable.
Issues
| Issue | Regeneron (Plaintiff) Argument | Merus (Defendant) Argument | Held |
|---|---|---|---|
| Whether withheld prior art was but-for material | Withheld refs are cumulative of art disclosed (Kucherlapati, Lonberg, Jakobovits); not dispositive to allowability | Withheld refs (Brüggemann, Wood, Taki, Zou) taught targeted insertion into Ig locus and would have prevented allowance | Court: Withheld refs were but-for material under BRC; PTO would not have allowed claims if aware |
| Whether Regeneron engaged in affirmative egregious misconduct to excuse but-for standard | Presentation and statements were accurate and non‑fraudulent advocacy | Presentation contained false/misleading statements (VelocImmune did not exist in 2001; claims about single‑step large replacements false) | Court: Clear and convincing evidence of egregious affirmative misconduct in prosecution |
| Whether Regeneron acted with specific intent to deceive the PTO | No specific intent; nondisclosure was judgment about materiality | Deliberate withholding of known material references and misleading statements to the PTO | Court: Adverse inference based on discovery/trial misconduct; found specific intent to deceive by clear and convincing evidence |
| Appropriate remedies for discovery/trial misconduct | Narrow remedies (e.g., strike limited evidence) sufficient | Broad sanctions warranted: preclude testimony, adverse inference, deny enforcement | Court: Precluded testimony of Smeland, Murphy, Jones re: prosecution; adverse inference that Smeland and Murphy knew materiality and deliberately withheld references; patent unenforceable |
Key Cases Cited
- Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (sets heightened but-for materiality and specific-intent standards for inequitable conduct)
- Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008) (discusses intent inference and overuse of inequitable-conduct claims)
- Residential Funding Corp. v. DeGeorge Fin. Corp., 306 F.3d 99 (2d Cir. 2002) (authorizes adverse inference sanctions for discovery misconduct)
- In re von Bulow, 828 F.2d 94 (2d Cir. 1987) (discusses subject-matter waiver of attorney-client privilege and fairness considerations)
- United States v. Bilzerian, 926 F.2d 1285 (2d Cir. 1991) (addresses sword-and-shield invocation of privilege and implied waiver)